Hematopoietic stem cell transplantation (HSCT) or gene therapy are the only definitive treatments for patients with SCID.[8]Buckley RH. Molecular defects in human severe combined immunodeficiency and approaches to immune reconstitution. Ann Rev Immunol. 2004:22:625-55.
http://www.ncbi.nlm.nih.gov/pubmed/15032591?tool=bestpractice.com
[47]Filipovich A. Hematopoietic cell transplantation for correction of primary immunodeficiencies. Bone Marrow Transplant. 2008 Aug;42 Suppl 1:S49-52.
http://www.ncbi.nlm.nih.gov/pubmed/18724301?tool=bestpractice.com
[48]Farinelli G, Capo V, Scaramuzza S, et al. Lentiviral vectors for the treatment of primary immunodeficiencies. J Inherit Metab Dis. 2014 Jul;37(4):525-33.
http://www.ncbi.nlm.nih.gov/pubmed/24619149?tool=bestpractice.com
HSCT is the principal therapy; gene therapy is an emerging technology.
Enzyme replacement therapy is available for patients with adenosine deaminase deficiency SCID.
Early diagnosis is critical, as infants who receive definitive treatment before the onset of infections have markedly improved long-term survival outcomes.[8]Buckley RH. Molecular defects in human severe combined immunodeficiency and approaches to immune reconstitution. Ann Rev Immunol. 2004:22:625-55.
http://www.ncbi.nlm.nih.gov/pubmed/15032591?tool=bestpractice.com
[23]Fischer A. Severe combined immunodeficiencies (SCID). Clin Exp Immunol. 2000 Nov;122(2):143-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1905779
http://www.ncbi.nlm.nih.gov/pubmed/11091267?tool=bestpractice.com
[24]Dvorak CC, Cowan MJ. Hematopoietic stem cell transplantation for primary immune deficiency disease. Bone Marrow Transplant. 2008 Jan;41(2):119-26.
http://www.ncbi.nlm.nih.gov/pubmed/17968328?tool=bestpractice.com
Supportive measures before curative treatment
The management of patients diagnosed with SCID before successful curative treatment (HSCT or gene therapy) includes the following measures to help reduce the risk of infections until there is evidence of immunocompetence:[4]Bonilla FA, Khan DA, Ballas ZK, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2015 Nov;136(5):1186-205.e1-78.
http://www.jacionline.org/article/S0091-6749(15)00883-0/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/26371839?tool=bestpractice.com
[21]Heimall J, Buckley RH, Puck J, et al. Recommendations for screening and management of late effects in patients with severe combined immunodeficiency after allogenic hematopoietic cell transplantation: a consensus statement from the second pediatric blood and marrow transplant consortium international conference on late effects after pediatric HCT. Biol Blood Marrow Transplant. 2017 Aug;23(8):1229-40.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015789
http://www.ncbi.nlm.nih.gov/pubmed/28479164?tool=bestpractice.com
[49]Bakare N, Menschik D, Tiernan R, et al. Severe combined immunodeficiency (SCID) and rotavirus vaccination: reports to the Vaccine Adverse Events Reporting System (VAERS). Vaccine. 2010 Sep 14;28(40):6609-12.
http://www.ncbi.nlm.nih.gov/pubmed/20674876?tool=bestpractice.com
Isolation from sick children and adults (hospitalization is not required)
Use of boiled, filtered water to prepare formula feeds
Immunoglobulin supplementation (may also be required after HSCT for persistent humoral immune deficiency)
Antibacterial prophylaxis
Antifungal prophylaxis
Antiviral prophylaxis
Avoiding live attenuated viral vaccines
If blood products are indicated, using irradiated blood products, leukocyte depleted, cytomegalovirus (CMV)-negative
Stopping breast-feeding, unless there is evidence that the mother is CMV negative.
HSCT
Overall survival rates of approximately 95% have been reported in patients who undergo HSCT for SCID within the first 3.5 months of life.[8]Buckley RH. Molecular defects in human severe combined immunodeficiency and approaches to immune reconstitution. Ann Rev Immunol. 2004:22:625-55.
http://www.ncbi.nlm.nih.gov/pubmed/15032591?tool=bestpractice.com
[10]Pai SY, Logan BR, Griffith LM, et al. Transplantation outcomes for severe combined immunodeficiency, 2000-2009. N Engl J Med. 2014 Jul 31;371(5):434-46.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4183064
http://www.ncbi.nlm.nih.gov/pubmed/25075835?tool=bestpractice.com
Stem cell transplantation with a human leukocyte antigen (HLA)-matched sibling donor is preferred and has been shown in multiple studies to provide better engraftment, immune reconstitution, and overall survival than unrelated HLA-matched or related HLA-mismatched donors.[10]Pai SY, Logan BR, Griffith LM, et al. Transplantation outcomes for severe combined immunodeficiency, 2000-2009. N Engl J Med. 2014 Jul 31;371(5):434-46.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4183064
http://www.ncbi.nlm.nih.gov/pubmed/25075835?tool=bestpractice.com
[24]Dvorak CC, Cowan MJ. Hematopoietic stem cell transplantation for primary immune deficiency disease. Bone Marrow Transplant. 2008 Jan;41(2):119-26.
http://www.ncbi.nlm.nih.gov/pubmed/17968328?tool=bestpractice.com
[50]Griffith LM, Cowan MJ, Kohn DB, et al. Allogeneic hematopoietic cell transplantation for primary immune deficiency diseases: current status and critical needs. J Allergy Clin Immunol. 2008 Dec;122(6):1087-96.
http://www.ncbi.nlm.nih.gov/pubmed/18992926?tool=bestpractice.com
[51]Grunebaum E, Mazzolari E, Porta F, et al. Bone marrow transplantation for severe combined immune deficiency. JAMA. 2006 Feb 1;295(5):508-18.
http://www.ncbi.nlm.nih.gov/pubmed/16449616?tool=bestpractice.com
Five-year survival is greatest among those patients who received transplants from matched sibling donors (97%); the comparable figure for patients receiving grafts from unrelated donors is 58% to 79% (depending on graft source and T-cell depletion).[10]Pai SY, Logan BR, Griffith LM, et al. Transplantation outcomes for severe combined immunodeficiency, 2000-2009. N Engl J Med. 2014 Jul 31;371(5):434-46.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4183064
http://www.ncbi.nlm.nih.gov/pubmed/25075835?tool=bestpractice.com
Unfortunately, protocols for HSCT in patients with SCID are not uniform, and multicenter collaborative studies are needed to formalize treatment and obtain standard optimal approaches.[50]Griffith LM, Cowan MJ, Kohn DB, et al. Allogeneic hematopoietic cell transplantation for primary immune deficiency diseases: current status and critical needs. J Allergy Clin Immunol. 2008 Dec;122(6):1087-96.
http://www.ncbi.nlm.nih.gov/pubmed/18992926?tool=bestpractice.com
[52]Griffith LM, Cowan MJ, Notarangelo LD, et al. Primary immune deficiency treatment consortium (PIDTC) report. J Allergy Clin Immunol. 2014 Feb;133(2):335-47.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3960312
http://www.ncbi.nlm.nih.gov/pubmed/24139498?tool=bestpractice.com
Enzyme replacement therapy
Patients with adenosine deaminase deficiency SCID can undergo enzyme replacement therapy with pegylated adenosine deaminase (PEG-ADA).[53]Kohn DB, Hershfield MS, Puck JM, et al. Consensus approach for the management of severe combined immune deficiency caused by adenosine deaminase deficiency. J Allergy Clin Immunol. 2019 Mar;143(3):852-63.
http://www.ncbi.nlm.nih.gov/pubmed/30194989?tool=bestpractice.com
However, it is not a definitive treatment, and serves as a temporary measure until definitive treatment (e.g., HSCT) can be performed.[12]Gaspar HB, Aiuti A, Porta F, et al. How I treat ADA deficiency. Blood. 2009 Oct 22;114(17):3524-32.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2766674
http://www.ncbi.nlm.nih.gov/pubmed/19638621?tool=bestpractice.com
[53]Kohn DB, Hershfield MS, Puck JM, et al. Consensus approach for the management of severe combined immune deficiency caused by adenosine deaminase deficiency. J Allergy Clin Immunol. 2019 Mar;143(3):852-63.
http://www.ncbi.nlm.nih.gov/pubmed/30194989?tool=bestpractice.com
Treatment with PEG-ADA has been shown to decrease lymphotoxic metabolites (adenosine and deoxyadenosine), and restore enzyme activity.[54]Chan B, Wara D, Bastian J, et al. Long-term efficacy of enzyme replacement therapy for adenosine deaminase (ADA)-deficient severe combined immunodeficiency (SCID). Clin Immunol. 2005 Nov;117(2):133-43.
http://www.ncbi.nlm.nih.gov/pubmed/16112907?tool=bestpractice.com
PEG-ADA is available as elapegademase, a recombinant adenosine deaminase based on bovine amino acid sequence and conjugated to monomethoxypolyethylene glycol. It is approved for the treatment of adenosine deaminase deficiency SCID.
Long-term outcomes in patients treated with PEG-ADA have not been prospectively studied, but immune reconstitution appears to be variable.[55]Booth C, Gaspar HB. Pegademase bovine (PEG-ADA) for the treatment of infants and children with severe combined immunodeficiency (SCID). Biologics. 2009;3:349-58.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2726071
http://www.ncbi.nlm.nih.gov/pubmed/19707420?tool=bestpractice.com
In a European cohort, continued immune globulin replacement was required in 40% of patients treated with PEG-ADA for one year, and overall survival among those who received PEG-ADA alone (i.e., no HSCT) was 85%.[56]Booth C, Hershfield M, Notarangelo L, et al. Management options for adenosine deaminase deficiency; proceedings of the EBMT satellite workshop (Hamburg, March 2006). Clin Immunol. 2007 May;123(2):139-47.
http://www.ncbi.nlm.nih.gov/pubmed/17300989?tool=bestpractice.com
Patients receiving enzyme replacement therapy for ADA-deficient SCID gradually develop decreased levels of T cells, B cells, and natural killer cells with suboptimal proliferative responses.[54]Chan B, Wara D, Bastian J, et al. Long-term efficacy of enzyme replacement therapy for adenosine deaminase (ADA)-deficient severe combined immunodeficiency (SCID). Clin Immunol. 2005 Nov;117(2):133-43.
http://www.ncbi.nlm.nih.gov/pubmed/16112907?tool=bestpractice.com